Lymphoma
Conditions
Brief summary
The purpose of this study is to evaluate the value of AMA in a comparative multicenter regional study as a reference for aggressive lymphoma. The primary endpoint will be RDI. This study consider that the AMA support should allow a significant improvement of the RDI compared to the control group and thus impact the duration without progression. The study covers 350 patients recruited from 10 regional centers.
Interventions
OTHERAMA (Assistance for ambulatory patients)
telephone follow-up modality
Sponsors
University Hospital, Toulouse
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient with a recent diffuse large B cell lymphoma (LBDGC), histologically proven, with treatment not started * a priori likely to be treated by rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone every 21 days (R-CHOP21) for 8 cycles or rituximab, doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (R-ACVBP). * Index international prognosis (IPI) measurable (IPI-aa), adjusted for age. Any IPI-aa is eligible. * accepting the study
Exclusion criteria
* Patient with another type of lymphoma (including transformed follicular forms) * Patient having already started his treatment. * Life expectancy \<3 months. * Carcinologic history * Serum positive for HIV or hepatitis B virus (HBV).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| dose-relative intensity (RDI) | through study completion, an average of 2 years | reduction of RDI |
Countries
France
Outcome results
None listed